FEATURED EDITORIAL

GUEST CONTRIBUTORS

  • Considerations For Biologic Drug Substance And Drug Product Testing
    Considerations For Biologic Drug Substance And Drug Product Testing

    Chief Editor’s Note: An Outsourced Pharma reader asked if we could do an article on the handling of incoming bulk drug substance: "The regulations are fuzzy, at best, and I haven’t been able to find any articles recently that cover the topic.” One of our contributing authors, Bikash Chatterjee, took on the challenge …

  • How AI Tools Will Transform Quality Management In The Life Sciences
    How AI Tools Will Transform Quality Management In The Life Sciences

    FDA officials and leaders in the pharma and medical device spaces agree artificial intelligence (AI) tools could enable a step change in quality management in those industries. Areas that could be impacted include supply chain management, lot release, manufacturing, compliance operations, clinical trial end points, and drug discovery, among others.

  • Prevent Sample Contamination Of ICP-MS Systems In Pharma Processing
    Prevent Sample Contamination Of ICP-MS Systems In Pharma Processing

    This article emphasizes the importance of implementing a regular routine maintenance for inductively coupled plasma mass spectrometry (ICP-MS) equipment, so problem areas associated with instrumental components that are most susceptible to sample blockage, drift, and signal instability can be avoided

More From Guest Contributors

PHARMA OUTSOURCING WHITE PAPERS

BioProcess Containers – Materials Of Construction BioProcess Containers – Materials Of Construction

This paper details some of the important characteristics of the plastic films used to manufacture BPCs, with a discussion on E&L and Thermo Fisher Scientific’s strategy for characterizing the extractables profiles of our BPC films.

6 Myths About Biocatalysis Every Manufacturer Should Ignore 6 Myths About Biocatalysis Every Manufacturer Should Ignore

By recognizing and dispelling the myths associated with biocatalysis, a manufacturer can reap the benefits of this valuable technology, providing a route to greener, safer chemistry that delivers a higher overall yield and reduced cost by virtue of the exceptional selectivity of enzymes.

A Guide To The Development Of Monoclonal Antibodies (mAb) Purification Platforms

The use of monoclonal antibodies (MAbs) and MAb conjugates as biopharmaceuticals have increased over the last decade. As a result, more cost-effective, efficient, and flexible process purification solutions are of high priority for MAb manufacturers. Increasing product titers upstream can introduce challenges in downstream purification processes. With increased MAb titers, the cell culture supernatant might contain an elevated number of impurities (e.g., aggregates) that need to be separated from the target molecule.

The Role Of Pharmaceutical Packaging Partners In Times Of Growth

The expanding global pharmaceutical industry projects a 4%-6% annual growth and forecasts that it will reach a value of $1T by 2014. By Paul Dupont

Scalable Strategies For Parenteral Dosage Form Selection

Understand the strategies which can be employed at the different stages of development when choosing parenteral dosage forms.

 

Continuous Processing Optimization With Smarter Tools

Due to a paradigm shift in the pharmaceutical industry, there is rising pressure to come up with faster, more cost-effective ways to produce drugs for the patients who need them.

More From OP White Papers - random

PHARMA OUTSOURCING APP NOTES & CASE STUDIES

Polishing Of Monoclonal Antibodies Using Capto™ S ImpAct

Capto S ImpAct chromatography medium (resin) is a strong cation exchanger (CIEX). The medium is designed for the polishing steps of monoclonal antibodies (MAbs) and a wide range of other biomolecules.

Improvements And Flexibility In Vaccine Development And Production

The growing public awareness of a potential pandemic requiring rapid treatment of millions of healthy individuals has spurred renewed interest in vaccines. Vaccine development timelines vary from being only a fraction of other biotherapeutics to decades of research and efforts to find an effective vaccine. Vaccination campaigns mean that often very large quantities need to be manufactured, maintained, and distributed.

Ovalbumin Removal In Egg-Based Influenza Vaccine Production

This application note demonstrates the performance of Capto Core 700 chromatography medium (resin) as an alternative for ovalbumin removal in the production of egg-based influenza vaccine.

Versatility Of Softgel Technology: The Encapsulation Of A Volatile Compound

A commercial stage medical technology company has developed SMART Softgels featuring a special shell to release quickly while still preventing evaporative loss during and after manufacturing. 

More Pharma Outsourcing App Notes & Case Studies

ABOUT US

Outsourced Pharma provides comprehensive analysis and exclusive content from thought leaders for the advancement of global outsourcing of drug development and manufacturing. We offer readers of our website and participants of our conferences – our Outsourced Pharma community – a deeper exploration and understanding of the relationships between pharmaceutical and biotechnology organizations with their service providers, and an open channel of communication.

About Outsourced Pharma Conferences
Outsourced Pharma Conference & Exhibition is a vibrant forum for thought-leadership and the application of best practices for professionals engaged in outsourcing drug development and manufacturing. These conferences and exhibitions form a community for networking and discussing topics most relevant to sponsor-provider partnerships and supply-chain management, within an open format that promotes panel and attendee interaction.

About OutsourcedPharma.com
OutsourcedPharma.com provides comprehensive analysis of global outsourcing, the biotechnology and pharmaceutical industries, and their intersection with the overall life sciences and healthcare markets. We offer readers a deeper exploration and understanding of the relationships between service providers and their bio and pharma sponsors.

Louis Garguilo Articles

CONNECT WITH US


@OUTSOURCEDPHARM

INDUSTRY INSIGHTS

  • Challenges, Risks And Strategies For Biologic Substance Manufacturing
    Challenges, Risks And Strategies For Biologic Substance Manufacturing

    From discussions with pharmaceutical and biotechnology industry leaders, it is clear that demand forecasting is a significant challenge when planning biologic drug substance production.

  • Are Today’s Processes Efficient Enough For The Future Of Vaccine And Viral Vector Production?
    Are Today’s Processes Efficient Enough For The Future Of Vaccine And Viral Vector Production?

    By recognizing the limitations of today’s production processes, the industry may be able to overcome the challenges, complexity, and high cost of manufacturing vaccines and viral vector-based therapies.

  • Determining The Right Type Of Biomanufacturing Capacity
    Determining The Right Type Of Biomanufacturing Capacity

    In selecting a biomanufacturing platform, it's necessary to properly understand what the industry needs are and what aspects of the drug development and clinical pathway you intend to support with your new manufacturing capacity. Having a rigorous selection and assessment criteria will ensure you make the right decision.

  • Iceland Manufacturer Builds Facility Designed for Drug Cost Savings
    Iceland Manufacturer Builds Facility Designed for Drug Cost Savings

    In June 2016, Alvotech opened their new biosimilar manufacturing facility in Reykjavik, Iceland, using best of breed solutions from leading Life Science vendors.  The key directive for Alvotech was to create a flexible, agile process which could adapt and be used for any conceivable process.  The result:  A high yield disposable fermentation and downstream process, with a fill-and-finish line for vials and prefilled syringes, tied together with a complete, end-to-end upstream/downstream automation and Manufacturing Execution System. 

  • Built To Fail: How Today’s Manufacturing Options Leave Pharma At Risk
    Built To Fail: How Today’s Manufacturing Options Leave Pharma At Risk

    Though pharma companies do their best to understand the environment, it can be very difficult to predict demand, and the consequences of incorrect forecasts can be very costly in a number of ways. 

More Industry Insights

OUTSOURCING EVENTS

Certified Copies and ALCOA-C: Essentials Post ICH GCP E6 (R2) Addendum April 23 - 23, 2018
April 23, 2018 | 1:00 - 2:30 PM EDT)
Duration:  90-Minutes
Price:  $299 - Includes Bonus Handouts!
Instructional Design for GMP Training – Improve Effectiveness and Measurability April 24, 2018
1pm-2:30pm EDT, Online Training)
Price:  $299 - Includes Bonus Handouts!
Measuring CAPA Effectiveness: Critical Tips in Getting the Right CAPA and Showing It Works April 25 - 25, 2018
2pm-3:30pm EDT, Online Training)
Duration:  90-Minutes
Price:  $299 - Includes Bonus Handouts!
The Top Method Validation Mistakes – And How to Avoid Them April 26 - 26, 2018
1pm-2:30pm EST, Online Training)
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
More Industry Events